Submitted by Jennifer Fuson on Tue, 07/09/2013 - 16:07
After 23 months, the U.S Food and Drug Administration (FDA) has finally agreed to look at the huge safety discrepancy between generic and brand named drugs. The FDA signaled the move by notifying the Office of Management and Budget of its plans to publish a proposed new rule that would make create similar requirements for generic and brand-name drug makers with respect to how they update their warning labels.
Submitted by Jennifer Fuson on Wed, 06/26/2013 - 11:31
In response to Monday's Supreme Court decision in Mutual v. Bartlett, ruling that generic drug companies cannot be held responsible for the design of the drugs they make, members of Congress have sent a letter to the FDA urging for action to address the disparity between the safety requirements for brand and generic drugs.
Submitted by Jennifer Fuson on Mon, 06/24/2013 - 16:51
The U.S. Supreme Court gave pharmaceutical companies another gift today, largely shielding the generic industry from lawsuits for the design of their drugs. This is the second Supreme Court decision giving the generic drug industry immunity.
Submitted by Jennifer Fuson on Tue, 06/11/2013 - 11:55
An outdated economic model allows unsafe trucking companies to operate on U.S. roads, according to a new report released today by the American Association for Justice (AAJ). “Truck Safety Alert: Rising Danger from Trucks and How to Stop It” details safety hazards in the trucking industry, including a compensation program that promotes fatigued driving and ignores safety risks, as well as inadequate insurance limits that shift the cost burden to taxpayers, medical insurance carriers, and Medicare.
Submitted by Jennifer Fuson on Thu, 05/16/2013 - 13:05
Michelle Garcia of Miami never thought a simple doctor’s office procedure for birth control would result in the removal of both of her fallopian tubes. Yet last year Michelle underwent surgery to remove Essure, a medical device marketed as a “surgery-free permanent” birth control procedure. It was supposed to be Michelle’s easy solution for birth control for life; instead, it was her worst nightmare, requiring surgery to remove the coils and both damaged fallopian tubes.
Women suffer disproportionately from faulty drugs and medical devices, and Michelle is just one example. As part of National Women’s Health Week, the American Association for Justice (AAJ) has released “Unequal Harm: The Disproportionate Damage to Women from Dangerous Drugs and Medical Devices,” an analysis detailing a history of a few of the many products that have harmed women over the years.
Submitted by Jennifer Fuson on Wed, 05/15/2013 - 15:05
As if we needed another example of the need to hold generic drug makers accountable to the same standard as brand names, there is this disturbing story from The New York Times. A drug maker named Ranbaxy was churning out generic versions of a number of common drugs, including the epilepsy drug, gabapentin. But in 2007, it admitted to the Food and Drug Administration that certain batches of the drug had tested positive for “unknown impurities.”
Submitted by Jennifer Fuson on Thu, 05/09/2013 - 11:44
78% of 2012 CPSC Recalls from Foreign Makers According to Analysis
Submitted by Jennifer Fuson on Fri, 04/19/2013 - 15:21
Taxpayers and patients could pay the price for faulty metal-on-metal hips when the U.S. Food and Drug Administration (FDA) reclassifies several metal-on-metal hips, requiring manufacturers to complete a premarket approval application (PMA) or product development protocol (PDP) in order to receive the agency’s approval. The reclassification may put patients’ legal rights in question.
Submitted by Jennifer Fuson on Wed, 04/10/2013 - 17:23
Submitted by Jennifer Fuson on Tue, 03/19/2013 - 12:17